[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100273800":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":35,"responsibleParty":117,"collaborators":19,"id":119,"slug":120,"hasResults":121,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":19,"eligibilityCriteria":125,"healthyVolunteers":121,"sex":126,"minAge":127,"maxAge":19,"enrollmentInfo":128,"targetDuration":19,"studyType":131,"phases":132,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":70,"whyStopped":19,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},{"fullName":5,"class":6},"CivaTech Oncology","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Directional Brachytherapy Source Implant","EXPERIMENTAL","Patients undergoing a pancreatic cancer resection will receive a CivaSheet LDR directional brachytherapy implant at the time of surgery. The directional nature of the FDA cleared CivaSheet is expected to allow physicians to increase the radiation dose given to the surgical margin safely, reducing risk of recurrence without increasing radiation side effects.",[13],"Device: Directional Brachytherapy Source Implant",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","The FDA Cleared CivaSheet Directional Pd103 Brachytherapy Source is a planar radiaiton source which utilizes gold shielding in its construction. This device is radioactive on one side only, and is capable of safely delivering high doses of radiation to target areas even when placed directly adjacent to sensitive, healthy tissue or critical structures.",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Joshua Meyer, MD","Fox Chase Cancer Center","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"Carra Castagnero","CONTACT","919-314-5515","ccastagnero@civatechoncology.com",{"name":32,"role":28,"phone":33,"phoneExt":19,"email":34},"Kristy Perez, PhD","9193145515","kperez@civatechoncology.com",[36,57,68,88,98,107],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Tampa General Hospital","NOT_YET_RECRUITING","Tampa","Florida","33612","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-82.45843,27.94752,{"lat":48,"lon":47},[51,55],{"name":52,"role":28,"phone":53,"phoneExt":19,"email":54},"Raegen Einsmann","813-974-7247","reinsmann@usf.edu",{"name":56,"role":24,"phone":19,"phoneExt":19,"email":19},"Timothy Nywening, MD",{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":42,"countryCode":43,"cosmosGeoPoint":63,"geoPoint":67,"contacts":19},"Rush University Cancer Center","COMPLETED","Chicago","Illinois","60612",{"type":45,"coordinates":64},[65,66],-87.65005,41.85003,{"lat":66,"lon":65},{"facility":69,"status":70,"city":71,"state":61,"zip":72,"country":42,"countryCode":43,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Advocate Christ Medical Center","RECRUITING","Oak Lawn","60453",{"type":45,"coordinates":74},[75,76],-87.75811,41.71087,{"lat":76,"lon":75},[79,83,85],{"name":80,"role":28,"phone":81,"phoneExt":19,"email":82},"Colleen Valenti, OCN","708-684-4694","colleen.valenti@advocatehealth.com",{"name":84,"role":24,"phone":19,"phoneExt":19,"email":19},"Paul Crossan, MD",{"name":86,"role":87,"phone":19,"phoneExt":19,"email":19},"Marc Mesleh, MD","SUB_INVESTIGATOR",{"facility":89,"status":59,"city":90,"state":91,"zip":92,"country":42,"countryCode":43,"cosmosGeoPoint":93,"geoPoint":97,"contacts":19},"University Medical Center LSU","New Orleans","Louisiana","70112",{"type":45,"coordinates":94},[95,96],-90.07507,29.95465,{"lat":96,"lon":95},{"facility":23,"status":59,"city":99,"state":100,"zip":101,"country":42,"countryCode":43,"cosmosGeoPoint":102,"geoPoint":106,"contacts":19},"Philadelphia","Pennsylvania","19111",{"type":45,"coordinates":103},[104,105],-75.16362,39.95238,{"lat":105,"lon":104},{"facility":108,"status":59,"city":109,"state":110,"zip":111,"country":42,"countryCode":43,"cosmosGeoPoint":112,"geoPoint":116,"contacts":19},"Virginia Commonwealth University Massey Cancer Center","Richmond","Virginia","23298",{"type":45,"coordinates":113},[114,115],-77.46026,37.55376,{"lat":115,"lon":114},{"type":118,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100273800","phase-1-initial-feasibility-study-to-treat-borderline-resectable-pancreatic-cancer-with-a-planar-ldr-source-100273800",false,"NCT02843945","Initial Feasibility Study to Treat Borderline Resectable Pancreatic Cancer With a Planar LDR Source","Initial Feasibility Study to Evaluate the Safety and Efficacy of the Permanently Implantable LDR CivaSheet® in Combination With External Beam Radiation in the Treatment of Pancreatic Cancer","Inclusion Criteria:\n\n* • Subject signed inform consent\n\n  * Age \\> 18 years\n  * Not pregnant or breast feeding\n  * Patient capable of undergoing anesthesia\n  * Patient selected to undergo Whipple procedure or distal pancreatectomy\n  * Patient does not have metastatic disease\n  * Patients will have close margins\n  * No prior radiation therapy to the region for separate cancer\n  * Confirmed diagnosis of borderline resectable or locally advanced pancreatic adenocarcinoma\n  * Patient Received neoadjuvant chemoradiation (4-10 weeks prior to surgery)\n  * Chemotherapy was administered for 2-6 cycles with any combination of the following agents:\n  * Gemcitabine + nb-paclitaxel\n  * FOLFIRINOX\n  * Neoadjuvant Chemoradiation was administered as IMRT or 3DCRT (up to 56 Gy), or SBRT (up to 36 Gy) with Pre-operative External beam dose (NCCN)\n  * up to 56 Gy (1.8-2.0 Gy per fractions) with concurrent gemcitabine, capecitabine, or infusional 5-fluorouracil\n\nExclusion Criteria:\n\n* Not surgical candidate\n* Any other invasive cancer in the past 5 years, except basal cell or squamous cell skin cancer\n* An IRE candidate (IRE is Percutaneous irreversible electroporation)\n* Recurrent or previously resected tumors\n* Documented History of Alcoholism and or drug abuse\n* Participant in other clinical trials","ALL","18 Years",{"count":129,"type":130},80,"ESTIMATED","INTERVENTIONAL",[133,134],"PHASE1","PHASE2","Initial study to evaluate local control and the preferred method of attachment of the CivaSheet in the setting of suspected close or positive margins at the time of surgical tumor removal.",[137],"Pancreatic Cancer",[139,140,141,142,143,144,145,146,147],"brachytherapy","CivaSheet","CivaTech","whipple","radiation","borderline resectable","locally advanced","Pd-103","intraoperative radiation","2025-06-16",{"date":150,"type":151},"2025-06-17","ACTUAL",{"date":153,"type":151},"2017-05-31",{"date":155,"type":130},"2028-10-30",{"name":5,"class":6},6]